Variable expansion frame system for deploying medical devices and methods of use

• US 6,494,895 B2
• Filed: 04/26/2001
• Issued: 12/17/2002
• Est. Priority Date: 08/03/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embolx, Inc.
• Inventors: Addis, Bruce
• Primary Examiner(s): Weiss, Howard
• Assistant Examiner(s): Trinh, (Vikki) Hoa B.
• Application Number:
  US09/844,895
• Publication Number:
  US 20010016755A1
• Time in Patent Office: 600 Days
• Field of Search: 606/200, 606/159, 606/108, 606/194, 606/198, 604/94-104
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

An expansion frame system for deploying medical devices in a patient'"'"'s body cavity. The system typically includes an inner wire disposed within a lumen of an outer wire. Distal ends of the inner and outer wires are attached to a substantially circular frame at first and second points. During use, the outer wire is displaced relative to the inner wire, causing the circular frame to rotate about an axis perpendicular to the line defined by the first and second points. Medical devices, such as a filter, a stent, an occluder or a manometer, can be mounted on the circular frame. The diameter of the expansion frame can be varied to achieve optimal contact with the luminal wall of the body cavity. Methods of using the expansion frame system for temporary or permanent placement of a medical device is disclosed.

Claims

1. A method for deploying a medial device within a body, comprising the steps of:

introducing an expansion frame into a blood vessel within the body of a patient, the expansion frame comprising an outer wire, an inner wire, and a substantially circular frame attached at a first point to a distal end of the outer wire, and attached at a second point to a distal end of the inner wire, the inner wire slideable relative to the outer wire;

advancing the expansion frame to a region of interest; and

retracting a proximal end of the outer wire relative to a proximal end of the inner wire,

wherein the circular frame rotates about an axis perpendicular to the line defined by the first and second point, and the circular frame thereby circumferentially engages the luminal wall.

2. The method of claim 1, wherein the expansion frame further comprises a filter mesh disposed about the circular frame.

3. The method of claim 1, wherein the expansion frame further comprises an impermeable membrane disposed about the circular frame.

4. The method of claim 1, wherein the vessel is an artery.

5. The method of claim 4, wherein the artery is an aorta.

6. The method of claim 4, wherein the artery is a carotid artery.

7. The method of claim 1, further comprising the step of performing an endoluminal procedure upstream of the expansion frame.

8. The method of claim 7, wherein embolic materials are dislodged during the procedure and captured by the expansion frame.

9. The method of claim 1, wherein the expansion frame is introduced through an incision by direct access.

10. The method of claim 1, wherein the expansion frame is introduced percutaneously.

11. The method of claim 1, wherein a radiopaque marker is mounted on the circular frame.

12. The method of claim 1, further comprising the step of verifying the position of the frame using fluoroscopy.

13. The method of claim 7, wherein the endolumenal procedure is performed by advancing an endolumenal instrument over the outer wire.

14. The method of claim 13, wherein the endolumenal instrument is an angioplasty catheter adapted to receive and be guided by the outer wire of the expansion frame.

15. The method of claim 13, wherein the endolumenal instrument is a stent deployment catheter adapted to receive and be guided by the outer wire of the expansion frame.

16. The method of claim 13, wherein the endolumenal instrument is an atherectomy catheter adapted to receive and be guided by the outer wire of the expansion frame.

17. The method of claim 13, wherein the endolumenal instrument is an imaging catheter adapted to receive and be guided by the outer wire of the expansion frame.

18. The method of claim 15, wherein the stent deployment catheter comprises:

a self-expanding stent disposed about the outer wire.

19. The method of claim 1, wherein the step of introducing the expansion frame into the vessel comprises advancing the expansion frame through an introducer.

20. The method of claim 19, wherein the introducer comprises a cannula.

21. The method of claim 19, wherein the introducer is a port on a cannula.

22. The method of claim 21, wherein the port is separate from a lumen of the cannula.

23. The method of claim 1, wherein the inner wire is disposed within the lumen of the outer wire.